BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUNCOAST DENTAL, INC.

    Reg #: 1054986 · FEI: 1000114355 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    110
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    SUNCOAST DENTAL, INC.
    Registration Number
    1054986
    FEI Number
    1000114355
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4500 140th Ave N Ste 112
    City
    CLEARWATER
    State
    FL
    ZIP
    33762
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213576

    Owner / Operator

    Firm Name
    SUNCOAST DENTAL, INC..
    Operator Number
    9003013
    Address
    4500 140th Avenue North, SUITE 112
    City
    Clearwater
    State
    FL
    Postal Code
    33762
    Country
    US
    Correspondent
    Tony Fiorello

    Products

    Device Name Product Code
    Instruments, Dental Hand DZN
    Elevator, Surgical, Dental EMJ
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Gauge, Depth, Instrument, Dental EIL
    Plate, Bone JEY
    Screw, Fixation, Intraosseous DZL
    Tray, Surgical, Instrument FSM
    Accessories, Implant, Dental, Endosseous NDP
    Drill, Dental, Intraoral DZA
    Tap, Bone HWX
    Curette, Surgical, General Use FZS
    Guide, Surgical, Instrument FZX
    Retractor, All Types EIG
    Mallet, Surgical, General & Plastic Surgery GFJ
    Positioner, Tooth, Preformed KMY
    Attachment, Precision, All EGG
    Chisel, Osteotome, Surgical EMM

    Proprietary Names

    Bone Caliper Retractor TC / UofM Scalpel Handle Bone Carrier Forceps Adson/Tissue/Micro Boley Gauge Bone Cutter Bone Expander Kit Orban Knife Tunneling Kit Post Holder Scissors Gfox/Metz/Castroviejo Straight/Curved EZ-Universal Driver Short/Long Bending Pliers Bone Molder Seldin Ruler EZ-Implant Driver EZ-Screw Fixation Driver Handle Needle Holder Periosteal Elevators Single/Kit Sinus Curette 1,2,3,4,5,6,7,8,9,10 Periotome 1,2,3,4,5,6,7 Suncoast Dental, Inc. Dba Tatum Surgical Suncoast Dental, Inc. Depth Gauge Tatum Surgical Integrity Implant Kit Box One-Piece Implant Kit Box Osteotome Box Periotome Box Small Stainless Tray Large Stainless Tray Sinus Box Tapered Implant Kit Box Autoclavable Cassette 4x7.5x1.5, 7.5x2.5, 6x10x0.75 Ht1 HT6U HT6 HT2 HT.18 HT7 HT3 Ratchet HT.26 HT8 HT.17 HT.23 HT.12 HT.30 HT.10 HT7D HT.15 HT.16 HT.20 HT.21 HT3L HT4 HT7L HT.29 HT6L HT5 HT.19 HT7U HT.27 HT.13A HT.22 HT9L HT.31A HT.32A HT.14 HT9 HT.11 Pilot Drill 1, 1.5, 1.8, 2 Tapered Drill 7x11,14,17 Tapered Drill 4x11,14,17,20 Tapered Drill 4.5x11,14,17,20 Tapered Drill 6x11,14,17,20 Tapered Drill 5x11,14,17,20 Tapered Drill 3.5x11,14,17,20 Tapered Drill 8x11,14,17 Tapered Tap 6x11, 6x14, 6x17, 6x20 Tapered Tap 7x11, 7x14, 7x17 Tapered Tap 8x11, 8x14, 8x17 Tapered Tap 4.5x11, 4.5x14, 4.5x17, 4.5x20 Tapered Tap 5x11, 5x14, 5x17, 5x20 Serrated Miller 9JS, 10S, 12S Post Guide Straight, 10, 20, 30 Paralleling Pin Tapered Socket Guide 3.3, 3.8, 4.3, 4.8 Rongeur Mallet Spacer Set 1, 2, 3, 4 Positioner Set 1, 2 Housing for Small/Large Ball Posts 3 Diameter Straight/Offset Osteotome 4.5 Diameter Straight/Offset Osteotome 4 Diameter Straight/Offset Osteotome RT Straight/Offset Osteotome BS Straight/Offset Osteotome 7 Diameter Offset Osteotome RB Straight/Offset Osteotome 5 Diameter Straight/Offset Osteotome BB Straight/Offset Osteotome 3.5 Diameter Straight/Offset Osteotome Channel Former D1,2,3,4 RP Straight/Offset Osteotome 8 Diameter Offset Osteotome D1,2,3,4 Straight/Offset Osteotome 6 Diameter Straight/Offset Osteotome

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility